Pular para o conteúdo principal
GE Healthcare · MRSigna60780

Details of the CADstream and PURE Important Product Information Letter and Customer Safety Letter (Urgent Field Safety N…

Details of the CADstream and PURE Important Product Information Letter and Customer Safety Letter (Urgent Field Safety Notice) for FMI 60780.

Symptom

What are the Details of the CADstream and PURE Important Product Information Letter and Customer Safety Letter (Urgent Field Safety Notice) for FMI 60780 ? See Long Description Customers with systems running the following software versions are being sent one of two letters relating to CADstream/PURE from GE Healthcare, depending on the customer's country : Software versions 11.1, 12.0, 15.0, HDe, 20.0, 20.1. Both letters deal with the same issue. Customers have been asking service personnel questions about these letters. Service personnel need to know these details now to be prepared for these questions. As of this writing on November 18, 2009 there is no service note nor IServe to explain the letters and associated FMI. What are the details of these letters? Both letters bear this subject heading: RE: Use of Confirma, Inc.’s CADstream in conjunction with GE Healthcare’s PURE option for dynamic MRI imaging The distribution of the Product Information letter (DOC0629119) will be exclusive to the Americas and Asian Poles (excluding Canada and Singapore) prior to the release of FMI 60780. The Customer Safety letter (Urgent Field Safety Notice - DOC0648683) will be sent only to the following countries (Canada, Singapore, and EEA countries in Europe) prior to the release of FMI 60780. The "European FMI Administrator has identified the specific countries.

Applies to

Models
Signa
Product
Signa HDxT This product is for 1.5T Signa HDxT systems with 15.0 software and HDi systems with 15.0 software. This product is for 1.5T Signa HDxT systems with 15.0 software and HDi systems with 15.0 software.
Software
15.0 For Product Signa HDxT and HDi only. -- NOT to be used with HDe. -- For Product Signa HDxT and HDi only. -- NOT to be used with HDe. --
Area
MR

Full cause & step-by-step resolution

The complete cause analysis, the step-by-step remedy for this GE Healthcare MR issue are available to FSELIB subscribers — re-authored, web-first, searchable.

7-day free trial · no credit card required

Related GE Healthcare MR issues